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CA#2 Regulatory Landscape – European Union

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CA#2 Regulatory Landscape – European Union Assignment help

Lecturer Name:Philip Byrne
Subject:Regulatory Landscape of Pharmaceutical Business
Assignment TitleCA#2 Regulatory Landscape – European Union
Assignment details: Part 1 of this assignment relates to the regulatory landscape of the Pharmaceutical Industry and Orphan Medicines.   Part 2 of the assignment relates to the application of Quality Risk Management
Part 1: 50% With reference to Orphan designation within the EU explain in YOUR OWN WORDS all relevant aspects of   Orphan designation: General Overview https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview Orphan designation: Research and development https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation-research-development Orphan designation: Marketing authorisation https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/orphan-designation-marketing-authorisation Orphan designation: post-authorisation https://www.ema.europa.eu/en/human-regulatory/post-authorisation/orphan-designation-post-authorisation   Include in your answer a comprehensive account of your opinion on whether the regulatory landscape of the Pharmaceutical Industry either enables or frustrates Orphan Medicine Innovation. Illustrate your argument with examples of drug products either classified as Orphan Medicines within the EU or under review.
Part 2: (50%) A company (ABC Pharmaceuticals) with a European Marketing Authorization for several Biopharmaceuticals have asked you to “Research and Develop” a procedure for dealing with Risk Management as required by the Eudralex Volume 4 Part 1. Your task is to conduct the research and then Write a Standard Operating Procedure. Consider any requirements relating to Chapters 1-9, Annexes 1, 2 8, 11, 15, 17, and 19 in your answer.
Word/Page count:Notes on this assignment: Part 1: Max word limit is 6000 words. Penalties may apply above the limit. Part 2: Max word limit is 6000 words. Penalties may apply above the limit. To be submitted / uploaded to Moodle before midday on 28th January 2022
Submission details:Submit softcopy of assignment in PDF/Word format on Moodle The document will be submitted to Turnitin. (Guideline % is 20% similarity or less.) This assignment will be worth 50% of the overall module marks

Additional Information:

Part 1 = 50%
 Clarity in the identification of relevant Regs or absence of Regs to the argument.Clarity on the identification / explanation of Innovative products.Variety and spread of the examples used to illustrate support/ frustration of InnovationComprehensiveness and persuasiveness of the argumentClarity of referencing
10151555
  Part 2 = 50%
 Recognition of Risk Management requirements across specific chapters and annexes.Ability to be able to apply Risk Management to specific chapters and annexes.Accuracy of the Procedure DevelopedClarity of referencing
1515105

Grading Scheme for the Assignment Part 1

Criteria DescriptorClarity in the identification of relevant Regs or absence of Regs to the argument.Clarity on the identification / explanation of Innovative products.Variety and spread of the examples used to illustrate support/ frustration of InnovationComprehensiveness and persuasiveness of the argumentClarity of referencing
Weighting to total 10010151555
70-100Great clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating extensive research. Demonstrating a full understanding of the topic, siting specific regulators and situations.Great clarity on the explanation of Innovative products /initiatives affected Demonstrating extensive research from peer regulatory sources and reviewed journals. Demonstrating a full understanding and application of the Innovative products/ initiatives affectedGreat Variety and spread of the examples used to illustrate support. Provides great examples citing how the regulation is required and its context. Demonstrating extensive research from peer reviewed journals. Demonstrating a full understanding and application of the Regulations.Evidence of extensive familiarity with the Regulation.       Clear understanding of the topic.Comprehensive referencing system
60-69Good clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating Good research. Demonstrating a good understanding of the topic, siting specific regulators and situations.Good clarity on the explanation of Innovative products /initiatives affected Demonstrating good research from peer regulatory sources and reviewed journals. Demonstrating a good understanding and application of the Innovative products/ initiatives affectedGood Variety and spread of the examples used to illustrate support. Provides good examples citing how the regulation is required and its context. Demonstrating good research from peer reviewed journals. Demonstrating a good understanding and application of the Regulations.Evidence of good familiarity with the Regulation.       Good understanding of the topic.Good referencing system
50-59Some clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating effective research. Demonstrating a some understanding of the topic, siting specific regulators and situations.Some clarity on the explanation of Innovative products /initiatives affected Demonstrating some research from peer regulatory sources and reviewed journals. Demonstrating a some understanding and application of the Innovative products/ initiatives affectedSome Variety and spread of the examples used to illustrate support. Provides some examples citing how the regulation is required and its context. Demonstrating effective research from peer reviewed journals. Demonstrating a some understanding and application of the Regulations.Evidence of some familiarity with the Regulation.       Some understanding of the topic.Acceptable referencing system
40-49Reasonable clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating some research. Demonstrating a reasonable understanding of the topic, siting specific regulators and situations.Reasonable clarity on the explanation of Innovative products /initiatives affected Demonstrating some research from peer regulatory sources and reviewed journals. Demonstrating adequate understanding and application of the Innovative products/ initiatives affectedReasonable Variety and spread of the examples used to illustrate support. Provides reasonable examples citing how the regulation is required and its context. Demonstrating little research from peer reviewed journals. Demonstrating a reasonable understanding and application of the Regulations.Evidence of reasonable familiarity with the Regulation.       Reasonable understanding of the topic.Limited referencing system
31-39Poor clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating poor research. Demonstrating a poor understanding of the topic, siting specific regulators and situations.Poor clarity on the explanation of Innovative products /initiatives affected Demonstrating poor research from peer regulatory sources and reviewed journals. Demonstrating poor understanding and application of the Innovative products/ initiatives affectedPoor Variety and spread of the examples used to illustrate support. Provides poor examples citing how the regulation is required and its context. Demonstrating little research from peer reviewed journals. Demonstrating a poor understanding and application of the Regulations.Evidence of poor familiarity with the Regulation.       Poor understanding of the topic.Poor referencing system
0-30Little / No clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating Little / No research. Demonstrating a Little / No understanding of the topic, siting specific regulators and situations.Little / No clarity on the explanation of Innovative products /initiatives affected Demonstrating Little / No research from peer regulatory sources and reviewed journals. Demonstrating Little / No understanding and application of the Innovative products/ initiatives affectedLittle / No Variety and spread of the examples used to illustrate support. Provides  Little / No   examples citing how the regulation is required and its context. Demonstrating Little / No research from peer reviewed journals. Demonstrating a Little / No understanding and application of the Regulations.Evidence of Little / No familiarity with the Regulation.       Little / No understanding of the topic.Inadequate referencing system

Grading Scheme for the Assignment Part 2

Criteria DescriptorRecognition of Risk Management requirements across specific chapters and annexes.Ability to be able to apply Risk Management to specific chapters and annexes.Accuracy of the Procedure DevelopedClarity of referencing
Weighting to total 1001515105
70-100Great clarity in the identification of the Risk Management Requirements. Demonstrating Great research. Demonstrating a very good understanding of the topic,Great clarity on Ability to be able to apply Risk Management to specific chapters and annexes. Demonstrating a full understanding and application of the Risk Management Guidelines.Great example of an Industry Procedure.   Demonstrating extensive research from peer reviewed journals.Comprehensive referencing system
60-69Good clarity in the identification of the Risk Management Requirements. Demonstrating Good research. Demonstrating a good understanding of the topic,Good clarity on Ability to be able to apply Risk Management to specific chapters and annexes. Demonstrating a good understanding and application of the Risk Management Guidelines.Good example of an Industry Procedure.   Demonstrating good research from peer reviewed journals.Good referencing system
50-59Some clarity in the identification of the Risk Management Requirements. Demonstrating some research. Demonstrating a some understanding of the topic,Some clarity on Ability to be able to apply Risk Management to specific chapters and annexes. Demonstrating a some understanding and application of the Risk Management Guidelines.Adequate example of an Industry Procedure.   Demonstrating some research from peer reviewed journals.Acceptable referencing system
40-49Reasonable clarity in the identification of the Risk Management Requirements. Demonstrating Reasonable research. Demonstrating a some understanding of the topic,Reasonable clarity on Ability to be able to apply Risk Management to specific chapters and annexes. Demonstrating Reasonable understanding and application of the Risk Management Guidelines.Reasonable example of an Industry Procedure.   Demonstrating Reasonable research from peer reviewed journals.Limited referencing system
31-39Poor clarity in the identification of the Risk Management Requirements. Demonstrating poor research. Demonstrating a poor understanding of the topic,Poor clarity on Ability to be able to apply Risk Management to specific chapters and annexes. Demonstrating  poor understanding and application of the Risk Management Guidelines.Poor example of an Industry Procedure.   Demonstrating poor research from peer reviewed journals.Poor referencing system
0-30Little/no clarity in the identification of the Risk Management Requirements. Demonstrating little/no research. Demonstrating a little/no understanding of the topic,Little/no clarity on Ability to be able to apply Risk Management to specific chapters and annexes. Demonstrating lttle/no understanding and application of the Risk Management Guidelines.Little/no example of an Industry Procedure.   Demonstrating Little/no research from peer reviewed journals.Little/no referencing system